Drug and Medical Device Approval Process in Saudi Arabia
This course provides a comprehensive analysis of the drug and medical device approval process in Saudi Arabia, highlighting the pivotal role of the Saudi Food and Drug Authority (SFDA) in ensuring safety, efficacy, and quality of healthcare products. It details the submission requirements, technical dossier content, and defined timelines for both drugs and medical devices, while showcasing advanced regulatory methodologies, such as risk-based assessments and electronic submission systems, that streamline approvals and enhance transparency. The course also emphasizes the critical importance of Health Economics and Outcomes Research (HEOR) in Health Technology Assessments (HTA), supporting evidence-based decision-making for regulatory approvals and market access. With a forward-looking perspective, the course explores opportunities in capacity building, digital transformation, and localized data infrastructure, underscoring Saudi Arabia's commitment to evolving its regulatory framework to foster innovation and meet the healthcare needs of its population.
Enrollment fee for full access is AED 775 ($210 USD)
Enrollment fee for full access is AED 775 ($210 USD)
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